Study to Evaluate the Efficacy and Safety of Staccato Apomorphine (AZ-009) in Patients With Parkinson's Disease Experiencing OFF Episodes

NCT05979415 on ClinicalTrials.gov Phase 2 Alexza Pharmaceuticals, Inc. (academic or other) Started 2023-09-27 Terminated

Riskier than 12% of active trials

Model scores of the 29,894 trials active now.

Model score 9% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 14% of the time (453 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Terminated on 2024-02-28, after 2023-09-27 start.

Reason given by the sponsor: “other”

The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.

Termination over time, as the model saw it at the start

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2024-02-28. The rest of the way to 100% is still running.

From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.

What moved the score

Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: mdsfirst dosepatienttherapystage
Phrases that lowered it: visitscreeningmsother protocolthe investigator
Accepts healthy volunteers: No (raises risk) · Who can join
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
Phase: 2 (raises risk) · Design
Disease area, neurology: Yes (raises risk) · Disease area
Minimum age: 30 (lowers risk) · Who can join
Drug's FAERS reports marked serious: 30.9% (lowers risk) · Drug's FDA history
Collaborators: 3 (lowers risk) · Design
Design: parallel (raises risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Blinding: quadruple (lowers risk) · Design
Sponsor type: academic or other (raises risk) · Sponsor's track record
Drug's FAERS reports with a death: 5.6% (lowers risk) · Drug's FDA history
Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
Has a data monitoring committee: No (lowers risk) · Design
Primary purpose: treatment (raises risk) · Design
Number of arms: 2 (raises risk) · Design

Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.

The trial

Design

Phase: 2
Number of arms: 2
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: quadruple (typical: none)
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 3 (typical: 0)
Keywords listed: 1

Who can join

Minimum age: 30 (typical: 18)
Maximum age: 85 (typical: 71)
Sex: all
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: academic or other
Sponsor's past trials: 24 (typical: 32)
Sponsor's past termination rate: 0% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 0 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 1
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 8299 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 668 (typical: 412.5)
Drug's FAERS reports marked serious: 30.9% (typical: 85.6%)
Drug's FAERS reports with a death: 5.6% (typical: 15.9%)

Disease area and drugs

Disease areas: neurology
Drugs matched to FDA substances: apomorphine

Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.

Similar finished trials

A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes) NCT03391882 · started 2018 · scored riskier than 10% of active trials completed
A Cardiac Safety Study of an Investigational Drug to See How if Affects the Heart in People With Parkinson's Disease Complicated by Motor Fluctuations OFF Episodes NCT03187301 · started 2017 · scored riskier than 22% of active trials completed
NE3107 Activity and Safety in Patients With Parkinson's Disease Using Levodopa NCT05083260 · started 2022 · scored riskier than 26% of active trials completed
A Study to Evaluate the Efficacy, Safety and Tolerability of SEP-363856 in Subjects With Parkinson's Disease Psychosis NCT02969369 · started 2016 · scored riskier than 50% of active trials completed
Study to Assess the Safety, Tolerability and Preliminary Efficacy of NLX-112 Versus Placebo in L-dopa-induced Dyskinesia NCT05148884 · started 2021 · scored riskier than 40% of active trials completed

Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.